WO2010117148A2 - Film médical multicouche, et son utilisation - Google Patents

Film médical multicouche, et son utilisation Download PDF

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Publication number
WO2010117148A2
WO2010117148A2 PCT/KR2010/001806 KR2010001806W WO2010117148A2 WO 2010117148 A2 WO2010117148 A2 WO 2010117148A2 KR 2010001806 W KR2010001806 W KR 2010001806W WO 2010117148 A2 WO2010117148 A2 WO 2010117148A2
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WO
WIPO (PCT)
Prior art keywords
polypropylene
multilayer film
styrene
copolymer
medical
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PCT/KR2010/001806
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English (en)
Korean (ko)
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WO2010117148A3 (fr
Inventor
최연석
김혜경
김은오
Original Assignee
주식회사 중외
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Priority to DE112010001528.7T priority Critical patent/DE112010001528B4/de
Priority to US13/263,008 priority patent/US9040132B2/en
Publication of WO2010117148A2 publication Critical patent/WO2010117148A2/fr
Publication of WO2010117148A3 publication Critical patent/WO2010117148A3/fr

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    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/06—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B27/08—Layered products comprising a layer of synthetic resin as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/30—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers
    • B32B27/302—Layered products comprising a layer of synthetic resin comprising vinyl (co)polymers; comprising acrylic (co)polymers comprising aromatic vinyl (co)polymers, e.g. styrenic (co)polymers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B27/00—Layered products comprising a layer of synthetic resin
    • B32B27/32—Layered products comprising a layer of synthetic resin comprising polyolefins
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/40—Properties of the layers or laminate having particular optical properties
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2307/00—Properties of the layers or laminate
    • B32B2307/40—Properties of the layers or laminate having particular optical properties
    • B32B2307/412—Transparent
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2439/00—Containers; Receptacles
    • B32B2439/80—Medical packaging
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B25/00—Layered products comprising a layer of natural or synthetic rubber
    • B32B25/04—Layered products comprising a layer of natural or synthetic rubber comprising rubber as the main or only constituent of a layer, which is next to another layer of the same or of a different material
    • B32B25/08—Layered products comprising a layer of natural or synthetic rubber comprising rubber as the main or only constituent of a layer, which is next to another layer of the same or of a different material of synthetic resin
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B32—LAYERED PRODUCTS
    • B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
    • B32B2535/00—Medical equipment, e.g. bandage, prostheses, catheter
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1303—Paper containing [e.g., paperboard, cardboard, fiberboard, etc.]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/1355—Elemental metal containing [e.g., substrate, foil, film, coating, etc.]
    • Y10T428/1359—Three or more layers [continuous layer]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/24—Structurally defined web or sheet [e.g., overall dimension, etc.]
    • Y10T428/24942—Structurally defined web or sheet [e.g., overall dimension, etc.] including components having same physical characteristic in differing degree
    • Y10T428/2495—Thickness [relative or absolute]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31855—Of addition polymer from unsaturated monomers
    • Y10T428/31909—Next to second addition polymer from unsaturated monomers
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/31504—Composite [nonstructural laminate]
    • Y10T428/31855—Of addition polymer from unsaturated monomers
    • Y10T428/31909—Next to second addition polymer from unsaturated monomers
    • Y10T428/31913—Monoolefin polymer

Definitions

  • the present invention is excellent in cold resistance, heat resistance, drop impact resistance and low temperature impact resistance as well as transparency, heat resistance, sealing property, such as a fluid container, medical pouch, contrast agent container and blood container for packaging and administering a medical solution such as fluid or blood.
  • the present invention relates to a medical multilayer film applicable, and a use thereof.
  • the chemical liquid packaging bag is required to have flexibility such as crushability, transparency that can easily observe the state of use of the solution, heat resistance that can endure high temperature sterilization, heat sealability, drop impact resistance and the like, and drug stability.
  • polyvinyl chloride has sufficient flexibility to provide excellent physical properties such as transparency, heat resistance, modulus and impact resistance during bag molding.
  • a compound such as DEHP, a plasticizer added for this purpose is harmful to the human body, and polyvinyl chloride is also reluctant to be used as a material harmful to the environment.
  • a technology for replacing this is provided in Korean Patent Application No. 2000-32659 "Medical Multi-Layered Film", but the present invention provides a resin composition for a film having more excellent cold resistance and impact resistance.
  • a medical container for packaging a chemical solution is subjected to heat sterilization for at least about 20 minutes under sterilization conditions of about 121 °C.
  • the medical container must have heat resistance, especially when the film outer layer is exposed to heated water vapor, can withstand high temperatures sufficiently.
  • the medical container may be broken when the film is subjected to an impact after being left in a low temperature condition, making the film impossible to use. Therefore, there is an urgent need to develop a film suitable for a medical container equipped with both heat resistance that can withstand heat sterilization and cold resistance and impact resistance at which the breakage rate is not high even under low temperature conditions.
  • the patent for the sap container is alpha in the inner layer through the Korean patent (registered 10-0275989, published 2004-0086373), US patent (US6017598, US6007529), Japanese patent (1994-286087, 2001-226499)
  • a film or container in the form of a single layer or a multilayer containing an olefin or a styrene polymer has been proposed.
  • the sap container is available in various forms, and typically consists of an inner bag containing the sap and an outer bag that wraps and protects the inner bag and provides gas barrier properties such as oxygen.
  • a functional sap bag having a plurality of (two or more) rooms and a flexible plastic container for a sap having one room are used.
  • the present invention aims to not only the transparency, heat resistance, sealing properties.
  • Another object of the present invention is to provide a fluid container, a medical pouch, a contrast agent container and a blood container for packaging and administering a medical solution such as a sap or blood, including the medical multilayer film.
  • An outer layer comprising one polypropylene polymer selected from the group consisting of polypropylene, polypropylene copolymers, and combinations thereof;
  • a middle layer comprising 10 to 60% by weight of one polypropylene polymer and 40 to 90% by weight of a thermoplastic elastomer selected from the group consisting of polypropylene, polypropylene copolymer, and combinations thereof;
  • Inner layer comprising 60 to 80% by weight of one polypropylene polymer, 10 to 30% by weight polyethylene, and 1 to 10% by weight thermoplastic elastomer selected from the group consisting of polypropylene, polypropylene copolymer, and combinations thereof
  • It provides a medical multilayer film comprising a.
  • the present invention provides an infusion container comprising the medical multilayer film.
  • the present invention provides a medical pouch comprising the medical multilayer film.
  • the present invention provides a contrast agent container comprising the medical multilayer film.
  • the present invention provides a blood container comprising the medical multilayer film.
  • the multilayer film is excellent in transparency, heat resistance, sealability as well as cold resistance, heat resistance, drop impact resistance and low temperature impact resistance.
  • Such a multilayer film can be applied as a fluid container, a medical pouch, a contrast agent container, and a blood container for packaging and administering a medical solution such as a sap or blood, and the manufactured container is useful for various medical industries due to its excellent cost competitiveness. do.
  • FIG. 1 is a cross-sectional view showing a multilayer film according to an embodiment of the present invention.
  • the multilayer film may include any additional layer, such as an adhesive layer, a vapor barrier layer, a gas barrier layer.
  • FIG. 1 is a cross-sectional view showing a multilayer film according to an embodiment of the present invention.
  • the medical multilayer film 10 is composed of an outer layer 2, a middle layer 4, and an inner layer 6.
  • the outer layer 2 protects the entire film and ensures proper physical properties to enable printing on its surface. That is, even if the inner layer is bonded, it should not affect the workability, so proper printability and heat resistance are required, and the composition design is made to ensure the container quality and to be suitable for the high speed process.
  • the material of this outer layer 2 includes one polypropylene polymer selected from the group consisting of polypropylene, polypropylene copolymer, and combinations thereof, and preferably, polypropylene is used.
  • the term 'polypropylene' is made using only propylene monomers, and includes all polypropylenes having isotactic, syndiotactic, and atactic structures.
  • a melt index (based on ASTM D1238) of 7 to 9 g / 10 minutes, a density of 0.85 to 0.95 and a softening point of 145 to 165 ⁇ are used.
  • polypropylene copolymer means a copolymer containing propylene as a main component and comonomer contained in a specific ratio.
  • polypropylene copolymers include propylene-ethylene copolymers containing propylene as a main component and ethylene contained as a comonomer;
  • a propylene-ethylene-alpha olefin copolymer containing propylene as a main component and containing ethylene and at least one alpha olefin as a comonomer is possible.
  • the alpha olefin is a hydrocarbon having 3 to 12 carbon atoms, for example, 1-butene, 1-pentene, 1-hexene, 4-methyl-1-pentene, 1-heptene, 1-octene, 1-nonene, 1-decene , 1-undecene and 1-dodecene, and combinations thereof are possible.
  • Such polypropylene copolymer may be in the form of a random copolymer, a block copolymer or a graft copolymer, and may be appropriately selected and used depending on the intended use. Moreover, also in the physical property, what has a range similar to the physical property of the said polypropylene is used.
  • the middle layer 4 is a layer containing a high amount of thermoplastic elastomer to secure flexibility and absorb shock, and particularly, it is advantageous to secure excellent drop impact resistance.
  • the material of the intermediate layer 4 includes a polypropylene polymer and a thermoplastic elastomer selected from the group consisting of polypropylene, polypropylene copolymer, and combinations thereof.
  • the polypropylene and polypropylene copolymers follow those mentioned in the outer layer 12.
  • the polypropylene copolymer is a random copolymer, and more preferably, the polypropylene copolymer has a melt index (based on ASTM D1238) of 6.5 to 8.5 g / 10 minutes and a density of 0.85 to 0.95. And a melting point of 120 to 140 ⁇ ⁇ and a softening point of 105 to 125 ⁇ ⁇ are used.
  • thermoplastic elastomer means a styrene-based elastomer, preferably a hydrogenated styrene-based elastomer.
  • Thermoplastic elastomers can have many advantages for the physical properties of the multilayer film 10 by having a wide range of flexibility and good restoring force.
  • the middle layer 4 according to the present invention adjusts the modulus of the multilayer film 10 by the content of the thermoplastic elastomer.
  • the content of the thermoplastic elastomer is a saturated type having excellent heat resistance and excellent low temperature impact while maintaining an appropriate amount, 40 to 90% by weight. Limited to thermoplastic styrene elastomers.
  • thermoplastic elastomers that can be used can be any saturated hydrogenated double bond of an unsaturated thermoplastic elastomer, and are typically hydrogenated SIBS (styrene-isoprene-butadiene block copolymer) and hydrogenated SBS (styrene- Butadiene-styrene copolymer), hydrogenated SIS (styrene-isoprene-styrene copolymer), hydrogenated SEBS (styrene-ethylene-butadiene block copolymer), hydrogenated SEPS (styrene-ethylene-propylene block copolymer), hydrogenated SEEPS (styrene- Ethylene-ethylene-propylene block copolymers), hydrogenated SBC (styrene-butadiene block copolymers), hydrogenated SBPS (styrene-ethylene-propylene-styrene copolymers), and combinations thereof. Hydrogenated SEBS is used below.
  • thermoplastic elastomer has a specific gravity of 0.85 to 0.95, a melt index (based on ASTM D1238) of 1 to 3 g / 10 minutes, and a 100% modulus of 0.5 to 0.7.
  • Such polypropylene-based polymers and thermoplastic elastomers are used by adjusting their content in consideration of their role and function as the intermediate layer 4. Preferably from 10 to 60% by weight of polypropylene polymer and from 40 to 90% by weight of thermoplastic elastomer. If the content of the polypropylene polymer is excessive, there is a problem that the flexibility is lowered, on the contrary, if the content of the thermoplastic elastomer is excessive, it is impossible to secure proper thermal stability.
  • Inner layer (6) is a layer present on the surface directly in contact with the chemical solution, the inner layer should be bonded to each other during the manufacture of the bag, so the ratio of the resin having a similar melting point is high, it is advantageous to select the processing conditions when processing medical containers.
  • the inner layer 6 according to the invention comprises one polypropylene polymer selected from the group consisting of polypropylene, polypropylene copolymers, and combinations thereof, as well as polyethylene and thermoplastic elastomers.
  • the melting point of the inner layer is usually low, so that it melts before the middle layer and the outer layer 2 to form a sealing.
  • the content of the polypropylene polymer is too high, the melting point of the inner layer 6 becomes too high, so that the heat resistance temperatures of the outer layer 2 and the inner layer 6 are similar to each other so that the outer layer 2 melts and sticks together with the middle layer 4 to seal. This becomes worse and requires an appropriate proportion of polyethylene and thermoplastic elastomer.
  • the ratio of the thermoplastic elastomer is limited to 1 to 10% by weight, which is a minimum amount, but in the case of the thermoplastic elastomer, the saturation type, that is, the low temperature impact property of the multilayer film 10 by using hydrogenated thermoplastic styrene elastomer
  • the ethylene alpha olefin copolymer as polyethylene, all of the elasticity, durability and workability of the multilayer film 10 are satisfied.
  • polypropylenes, polypropylene copolymers and thermoplastic elastomers used for the inner layer 6 are as described above.
  • the polypropylene copolymer is a random copolymer, more preferably 6.5 to 8.5 g / 10 minutes, density 0.85 to 0.95, melting point 120 to 140 with a melt index (based on ASTM D1238). And a softening point of 105 to 125 ° C is used.
  • thermoplastic elastomer has a specific gravity of 0.85 to 0.95, a melt index (based on ASTM D1238) of 1 to 3 g / 10 minutes, and a 100% modulus of 0.5 to 0.7.
  • the polyethylene can be any known form of polyethylene, including low density polyethylene (LDPE), linear low density polyethylene (LLDPE), high density polyethylene (HDPE), ultra high density polyethylene (VLDPE), and copolymers with alphaolefins, preferably polyethylene Alphaolefin copolymers are used. More preferably, the polyethylene has a melt index (based on ASTM D1238) of 4 to 6 g / 10 minutes, a density of 0.8 to 1.0, and a melting point of 50 to 120 ° C. Preferably, the polyethylene uses a copolymer of ethylene and alpha olefins.
  • LDPE low density polyethylene
  • LLDPE linear low density polyethylene
  • HDPE high density polyethylene
  • VLDPE ultra high density polyethylene
  • copolymers with alphaolefins preferably polyethylene Alphaolefin copolymers are used. More preferably, the polyethylene has a melt index (based on ASTM D1238) of 4 to 6 g
  • the inner layer 6 comprises 60 to 80% by weight polypropylene polymer, 10 to 30% by weight polyethylene and 1 to 10% by weight thermoplastic elastomer. This content range is to ensure the physical properties for performing the function as the inner layer 6 as described above, outside this range it is not possible to sufficiently secure the effects of the above.
  • the multilayer film 10 composed of the outer layer 2 / the middle layer 4 / the inner layer 6 as described above can be used in any or all layers of the multilayers of the present invention if desired.
  • the additives are not limited in the present invention, and known additives used in the art may be used, and examples thereof include antioxidants, anti-sticking agents, processing aids, pigments, antistatic agents, and the like.
  • the content of the additive is preferably kept in a minimum amount in order to minimize the extraction into the medical solution during the heat-sterilization.
  • Multi-layer film 10 is produced by adjusting the thickness of each layer to have a proper physical properties so that it can be applied to a medical container.
  • the outer layer is 3-20% of the total thickness and the middle layer is 60-94%, and the inner layer is 3-20%.
  • the thickness of the outer layer 2 is 5 to 60 ⁇ m
  • the thickness of the middle layer 4 is preferably 110 to 250 ⁇ m
  • the thickness of the inner layer 6 is 5 to 60 ⁇ m. If the thickness of each layer is less than the above range, the effect to be obtained through the configuration of each layer may not be sufficiently secured.
  • the heat resistance is lowered if the thickness is less than the thickness.
  • the outer layer 12 is exceeded, the flexibility of the entire film is lowered and the heat sealability is lowered.
  • the multilayer film 10 according to the present invention basically performs adhesion at a temperature slightly lower than the melting point of the material used.
  • fusing point of the outer layer 2 is 145-165 degreeC
  • middle layer 4 is 140-155 degreeC
  • the inner layer 6 has the range of 125-140 degreeC.
  • Medical multilayer film according to the present invention is not particularly limited in the present invention, it can be produced using a method known in the art.
  • the multilayer film is capable of co-extrusion and lamination of the film and the film.
  • the co-extrusion method is a method of melting two or more different raw materials in different extruders to send the molten resin into the die, stacking them in multiple layers, and cooling the multilayered raw materials in various ways.
  • the coextrusion method can form a resin extrudate of constant thickness with improved efficiency, and there is little deterioration of the resin during extrusion, and as a result, the layers maintain their respective properties to obtain a product having high transparency and flexibility. There is an advantage to that.
  • the coextrusion method is divided into an inflation method using a circular die and a T-die method using a flat die. The inflation method is used in terms of managing cleanliness of the film, and the T-die method is used in securing thickness uniformity. useful.
  • the production of the multilayer film by coextrusion is carried out at 170 to 250 ° C, preferably at 200 to 230 ° C. At this time, it is preferable that the resin forming each resin has a small difference in melt flow rate (MFR) therebetween in order to make thickness and extrudability uniform.
  • MFR melt flow rate
  • the multilayer film thus prepared has appropriate haze properties, thermal adhesive strength, tensile strength, modulus and elongation as well as the physical properties as described above for use in various medical containers.
  • the multilayer film has a thickness (ASTM D 882) of 180 to 250 ⁇ m, haze after sterilization (ASTM D 1003) 10% or less, tensile strength (ASTM 882) is 250 kgf / cm 2 or more , Modulus (ASTM D 882) is 300 ⁇ 1200kgf / cm 2 , elongation (ASTM 882) has more than 900%.
  • it has appropriate impact resistance at room temperature and low temperature.
  • the medical multilayer film according to the present invention is applicable to monobag or multichamber bag medical containers for general infusion products.
  • the medical multilayer film may be used as various fluid containers, medical pouches, contrast medium containers, or blood containers requiring high drop impact resistance.
  • Such a medical container has a high drop resistance and low temperature impact resistance due to a multilayer film, which greatly reduces the risk of damage during transportation or handling, and at the same time, cost competitiveness is achieved due to the use of a suitable raw material.
  • HOMO PP melt index 8 g / 10 min, density 0.90, softening point 150 ° C, Honam Petrochemical
  • SEBS specific gravity 0.90, melt index 2 g / 10 min, 100% modulus 0.6 MPa, KRATON products
  • SEBS specific gravity 0.95, melt index 2 g / 10 min, 100% modulus 0.6 MPa, Kumho Petrochemical
  • PE Melt index 5 g / 10 min, density 0.95, melting point 60 ° C., DOW CHEMICAL
  • Haze was 10% or less, good, 10 to 20% is normal, and 20% or more was indicated as insufficient.
  • the drop impact resistance was expressed in% by checking the amount of burst BAG by testing more than 30 EA of the minimum quantity of water drop per BAG (free fall at 1.8m height) in each drop direction after sterilization. At this time, the impact resistance at room temperature drop was tested after storage for 7 days at 23-25 ° C. (chemical temperature; 23-25 ° C.) after sterilization, and the drop resistance at low temperature was 4-5 ° C. (chemical temperature; 4-5 ° C.) after sterilization. Test after storage for 5 days at.
  • the multilayer films of Examples 1 to 3 according to the present invention showed excellent results in all properties.
  • a multilayer film was prepared by the above-mentioned method, but was prepared by varying the thickness of each layer as shown in Table 3 below, and measured physical properties. At this time, the multilayer film was to have a composition as shown in Example 2.
  • the multilayer films of Examples 4 to 6 according to the present invention showed excellent results in all properties.
  • the multilayer films of Comparative Examples 6 and 7 have low haze characteristics and sealing properties, and drop impact resistance is also greatly reduced.
  • the outer layer is thin and the thickness of the middle layer is relatively thick, so that the content of the thermoplastic elastomer in the middle layer in the entire multilayer film is relatively increased, resulting in poor haze.
  • heat resistance may be insufficient, resulting in the outer layer sticking.
  • the medical multilayer film according to the present invention can be used as an infusion container, medical pouch, contrast medium container, or blood container.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Laminated Bodies (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

La présente invention a pour objet un film médical multicouche et son utilisation, et plus particulièrement un film médical multicouche comprenant : une couche externe comprenant un type de polymère de polypropylène choisi dans le groupe comprenant le polypropylène, un copolymère de polypropylène, et leur combinaison ; une couche intermédiaire comprenant de 10 à 60 % en poids d'un type de polymère de polypropylène choisi dans le groupe comprenant le polypropylène, un copolymère de polypropylène, et leur combinaison, et de 40 à 90 % en poids d'un élastomère thermoplastique ; et une couche interne comprenant de 60 à 80 % en poids d'un type de polymère de polypropylène choisi dans le groupe comprenant le polypropylène, un copolymère de polypropylène, et leur combinaison, de 10 à 30 % en poids de polyéthylène, et de 1 à 10 % en poids d'un élastomère thermoplastique. La présente invention concerne aussi l'utilisation du film. Le film multicouche possède une excellente transparence, une excellente résistance à la chaleur, d'excellentes propriétés de scellage, une excellente résistance au froid, une excellente résistance aux chocs en cas de chute, et une excellente résistance aux chocs en cas de basses températures, et peut par conséquent être utilisé dans des réceptacles pour sève pour l'emballage et l'administration d'un liquide médical tel que la sève ou le sang, des poches médicales, des récipients pour produits de contraste et des récipients pour le sang.
PCT/KR2010/001806 2009-04-06 2010-03-24 Film médical multicouche, et son utilisation WO2010117148A2 (fr)

Priority Applications (2)

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DE112010001528.7T DE112010001528B4 (de) 2009-04-06 2010-03-24 Medizinischer Mehrlagen-Film und Verwendung davon
US13/263,008 US9040132B2 (en) 2009-04-06 2010-03-24 Medical multilayer film and use thereof

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KR10-2009-0029396 2009-04-06
KR1020090029396A KR101091528B1 (ko) 2009-04-06 2009-04-06 의료용 다층 필름, 및 이의 용도

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WO2010117148A3 WO2010117148A3 (fr) 2010-12-23

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WO2020020825A1 (fr) 2018-07-23 2020-01-30 Borealis Ag Film en polypropylène multicouche
WO2020245251A2 (fr) 2019-06-05 2020-12-10 Borealis Ag Film en polypropylène multicouche
WO2021110615A1 (fr) 2019-12-05 2021-06-10 Borealis Ag Film multicouche possédant des propriétés améliorées
EP3912794A1 (fr) 2020-05-18 2021-11-24 Borealis AG Film multicouche présentant des propriétés améliorées

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JP6790814B2 (ja) * 2016-02-03 2020-11-25 日本ポリプロ株式会社 ポリプロピレン樹脂フィルムおよびそれを用いた加熱処理用包装体
WO2019068747A1 (fr) 2017-10-03 2019-04-11 Sabic Global Technologies B.V. Composition de polyoléfines
KR102551304B1 (ko) * 2017-11-30 2023-07-03 롯데케미칼 주식회사 투명성, 연질성 및 내충격성이 우수한 의료용 필름
CN109517206B (zh) * 2018-12-06 2020-04-07 中国科学院长春应用化学研究所 一种sebs基复合膜、其制备方法及输液器
KR102291839B1 (ko) * 2020-03-03 2021-08-23 주식회사 한서마이크론 Pe/pp 합지필름 대체용 고온 추출액 포장용 공압출 필름
KR102239192B1 (ko) * 2020-09-28 2021-04-12 이승영 공압출, 다층 구조를 갖는 의료용 필름
KR102434725B1 (ko) * 2020-11-09 2022-08-22 주식회사 미르앤씨 비-pvc 다층 필름
KR102239194B1 (ko) * 2020-12-01 2021-04-12 이승영 이지필 기능을 갖는 의료용 다층 필름
KR102294590B1 (ko) * 2020-12-30 2021-09-01 (주)엠디에스 의료용 액상 용기용 튜브
EP4304861A1 (fr) 2021-03-09 2024-01-17 PolyCine GmbH Film multicouche flexible non pvc stérilisable à la chaleur pour emballages médicaux
KR102399031B1 (ko) * 2021-04-30 2022-05-18 주식회사 한서마이크론 건축 마감용 단프라 데코보드
WO2023170022A1 (fr) * 2022-03-10 2023-09-14 Loparex Germany Gmbh & Co. Kg Film de séparation emboutissable par emboutissage profond pour composants en matière plastique composite à base de fibres

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US11440300B2 (en) 2018-07-23 2022-09-13 Borealis Ag Multilayer polyproylene film
WO2020245251A2 (fr) 2019-06-05 2020-12-10 Borealis Ag Film en polypropylène multicouche
US11752743B2 (en) 2019-06-05 2023-09-12 Borealis Ag Multilayer polypropylene film
WO2021110615A1 (fr) 2019-12-05 2021-06-10 Borealis Ag Film multicouche possédant des propriétés améliorées
EP3912794A1 (fr) 2020-05-18 2021-11-24 Borealis AG Film multicouche présentant des propriétés améliorées
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Also Published As

Publication number Publication date
US9040132B2 (en) 2015-05-26
KR101091528B1 (ko) 2011-12-13
US20120034404A1 (en) 2012-02-09
DE112010001528T5 (de) 2012-06-14
KR20100111036A (ko) 2010-10-14
DE112010001528B4 (de) 2020-09-24
WO2010117148A3 (fr) 2010-12-23

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